Focal Segmental GlomerulosclerosisFSGSNCT02194582
Genetic Causes of FSGS, Nephrotic Syndrome, or Kidney Failure
An observational study of Focal Segmental Glomerulosclerosis and Nephrotic Syndrome, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The investigators are trying to learn more about the cause of kidney diseases such as Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic syndrome by studying genetics. The investigators are interested in discovering which genes play a role in causing a predisposition to FSGS/NS. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Focal Segmental Glomerulosclerosis, Nephrotic Syndrome, End Stage Renal Disease
- How many people
- 2,050 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1996to Jan 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: We are recruiting subjects who have kidney disease, family members of a person with kidney disease, and healthy controls.
Who may be able to join
- Subjects with FSGS (focal segmental glomerulosclerosis)
- Subjects with NS (nephrotic syndrome)
- Subjects with unexplained kidney failure (have had a transplant or on dialysis)
- Subjects with unexplained proteinuria
- Family members of a person with FSGS, NS, kidney failure, or unexplained protein in their urine
- Healthy volunteers
Who cannot join
- Patients whose kidney disease is already explained by another syndrome such as (Branchio Oto Renal Syndrome or Alports syndrome)
- Patients who already know the genetic cause of their kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecular and Genetic Analysis of Inherited Kidney Dysfunction
The investigators are trying to learn more about the cause of kidney diseases such as Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic syndrome by studying genetics. The investigators are interested in discovering which genes play a role in causing a predisposition to FSGS/NS. The investigators also want to learn why FSGS/NS can run in families. Participation in our study involves a saliva sample and a urine sample that you can give from home. There is no cost to participate. All information is kept private and confidential. The investigators also like to include healthy volunteers (parents, spouses) if interested/available but of course this is completely optional.
Read the detailed description
The investigators welcome anyone (with or without a family history) with unexplained, non syndromic FSGS, nephrotic syndrome, or proteinuria to join the study. Participation involves a saliva (or blood if it is preferable) sample and urine sample (if applicable). There is no cost to participate and the study can be done from home in most cases.
- Conditions
- Focal Segmental Glomerulosclerosis, Nephrotic Syndrome, End Stage Renal Disease, Kidney Failure, Unexplained Proteinuria
- Keywords
- FSGS, NS, Kidney disease, Kidney failure, Renal disease, nephrotic syndrome, focal segmental glomerulosclerosis, familial kidney disease, minimal change disease, proteinuria
- Medical subject headings
- Glomerulosclerosis, Focal Segmental, Nephrotic Syndrome, Kidney Failure, Chronic, Renal Insufficiency, Kidney Diseases, Nephrosis, Lipoid, Proteinuria
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the genetic causes of FSGS, NS, and idiopathic proteinuria/ESRD in patients and families
This is an ongoing study for research purposes only.
Measured: 2035
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startJun 1996
- Primary completionJan 2035 (estimated)
- Study completionJan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Segmental GlomerulosclerosisStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 2,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), United States Department of Defense
- Responsible party
- Principal investigator, Martin R. Pollak, Beth Israel Deaconess Medical Center
- Investigators
- Martin R Pollak, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194582
- Sponsor's protocol ID
- 2009P000430
- Other IDs
- 5RC2DK122397
- Acronym
- FSGS
- Status last verified
- Jun 2026
- First submitted
- 16 Jul 2014
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Genetic Analysis of Inherited Kidney Dysfunction
- ClinicalTrials.gov ID
- NCT02194582
- Acronym / sponsor ID
- FSGS / 2009P000430
- Conditions
- Focal Segmental Glomerulosclerosis, Nephrotic Syndrome, End Stage Renal Disease, Kidney Failure, Unexplained Proteinuria
- Keywords
- FSGS, NS, Kidney disease, Kidney failure, Renal disease, nephrotic syndrome, focal segmental glomerulosclerosis, familial kidney disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,050 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), United States Department of Defense
- Study start
- Jun 1996 (actual)
- Primary completion
- Jan 2035 (estimated)
- Study completion
- Jan 2035 (estimated)
- First posted
- 18 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are trying to learn more about the cause of kidney diseases such as Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic syndrome by studying genetics. The investigators are interested in discovering which genes play a role in causing a predisposition to FSGS/NS. The investigators also want to learn why FSGS/NS can run in families. Participation in our study involves a saliva sample and a urine sample that you can give from home. There is no cost to participate. All information is kept private and confidential. The investigators also like to include healthy volunteers (parents, spouses) if interested/available but of course this is completely optional.
Detailed description
The investigators welcome anyone (with or without a family history) with unexplained, non syndromic FSGS, nephrotic syndrome, or proteinuria to join the study. Participation involves a saliva (or blood if it is preferable) sample and urine sample (if applicable). There is no cost to participate and the study can be done from home in most cases.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We are recruiting subjects who have kidney disease, family members of a person with kidney disease, and healthy controls.
Key inclusion criteria (6 listed)
- Subjects with FSGS (focal segmental glomerulosclerosis)
- Subjects with NS (nephrotic syndrome)
- Subjects with unexplained kidney failure (have had a transplant or on dialysis)
- Subjects with unexplained proteinuria
- Family members of a person with FSGS, NS, kidney failure, or unexplained protein in their urine
Key exclusion criteria (2 listed)
- Patients whose kidney disease is already explained by another syndrome such as (Branchio Oto Renal Syndrome or Alports syndrome)
- Patients who already know the genetic cause of their kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To identify the genetic causes of FSGS, NS, and idiopathic proteinuria/ESRD in patients and families
Time frame: 2035
This is an ongoing study for research purposes only.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- BIDMC - Pollak Lab WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin R Pollak, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focal Segmental Glomerulosclerosis and Nephrotic Syndrome, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify the genetic causes of FSGS, NS, and idiopathic proteinuria/ESRD in patients and families (time frame: 2035). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.